About this trial
Using a randomized, placebo-controlled, crossover study, this study will evaluate functional magnetic resonance imaging (fMRI) as a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders. The hypothesis is that fMRI will be able to detect acute reward pathway modulation by naltrexone (an opioid antagonist) in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex).
Eligibility criteria
Qualifiers
Adolescents and young adults aged 13-21 years
Eating disorder diagnosis characterized by binge eating and/or purging (eg, Anorexia Nervosa-Binge/Purge, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding/Eating Disorder) using Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria.
Stable medication regimen (no dose or drug changes in the past 4 weeks)
Participant and parent/legal guardian (if under 18 years) are willing and able to provide informed permission/assent/consent for the study
Disqualifiers
Pregnant (via UCG)
Prior hypersensitivity reaction to naltrexone (e.g., anaphylaxis)
Non-removable metal in the body that is magnetic resonance imaging incompatible
Current naltrexone use
Trial design
Treatments tested in this trial
- Naltrexone
- Placebo
Treatment groups
Sponsors and collaborators
Children's Mercy Hospital Kansas City
Lead sponsor
University of Kansas Medical Center
Collaborator
National Institute of Mental Health (NIMH)
Collaborator